EUCTR2019-002735-28-DE进行中（未招募）1 期
The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT) - SURPASS-CVOT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] Men or women at least 40 years old with a diagnosis of T2DM (WHO
- •[2] Established CVD, including at least 1 of the following (a-c):
- •a. Coronary artery disease (CAD) with ANY of the following:
- •- Documented history of spontaneous MI
- •- =50% stenosis in 1 or more major coronary arteries, determined by
- •invasive angiography
- •- =50% stenosis in 2 or more major coronary arteries, determined by
- •computed tomography coronary angiography (CTCA), or
- •- History of surgical or percutaneous coronary revascularization
- •b. Cerebrovascular disease – ANY of the following:
- •- Documented history of ischemic stroke
- •- Carotid arterial disease with =50% stenosis, documented by carotid
- •ultrasound, magnetic resonance imaging (MRI), or angiography
- •- Carotid stenting or surgical revascularization;
- •c. Peripheral arterial disease with EITHER of the following:
- •- Intermittent claudication and ankle-brachial index <0.9
- •- Prior nontraumatic amputation or peripheral vascular procedure (eg,
- •stenting or surgical revascularization), due to peripheral arterial
- •[3] HbA1c =7% (=53 mmol/mol) and =10.5% (=91.3 mmol/mol) based
- •on central laboratory assessment at screening.
- •[4] Body mass index (BMI) =25 kg/m2.
- •[5] At the time of signing the informed consent: Contraceptive use by
- •men or women should be consistent with local regulations regarding the
- •methods of contraception for those participating in clinical trials.
- •[6] In the investigator's opinion, patients are well motivated, capable,
- •and willing to learn how to self-inject treatment (tirzepatide or
- •dulaglutide), as required for this protocol (visually impaired persons
- •and/or persons with physical limitations who are not able to perform the
- •injections must have the assistance of an individual trained to inject the
- •study drug).
- •[7] Patients are capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6250
排除标准
- •[8] Have type 1 diabetes mellitus.
- •[9] Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician.
- •[10] Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening.
- •[11] Are currently planning treatment for diabetic retinopathy and/or
- •macular edema.
- •[12] Have been hospitalized for CHF within 2 months prior to screening.
- •[13] Have chronic New York Heart Association Functional Classification IV CHF.
- •[14] Are currently planning a coronary, carotid, or peripheral artery revascularization.
- •[15] Had chronic or acute pancreatitis any time prior to screening, irrespective of etiology.
- •[16] Have a known clinically significant gastric emptying abnormality
- •such as severe gastroparesis or gastric outlet obstruction or have
- •undergone or currently planning any gastric bypass (bariatric) surgery
- •or restrictive bariatric surgery.
- •[17] Have acute or chronic hepatitis, signs or symptoms of any other liver disease, an alanine aminotransferase (ALT) level =3X the upper limit of normal (ULN) for the reference range, as determined by the central laboratory.
- •[18] Have known chronic severe renal failure (defined as a known eGFR <15 mL/minute/1.73 m2) or are on chronic dialysis.
- •[19] Have evidence of a significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis or adrenal crises).
- •[20] Have a family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (MTC) or personal history of nonfamilial MTC.
- •[21] Have a serum calcitonin level at screening of: (based on central laboratory results)
- •- =20 ng/L at Visit 1, if eGFR =60 mL/min/1.73 m2, or
- •- =35 ng/L at Visit 1, if eGFR <60 mL/min/1.73 m2.
- •[22] Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years. An exception for this criterion is basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer.
- •[23] Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol.
- •[24] Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant.
- •[25] Have any other condition (eg, hypersensitivity) that is a contraindication to any incretin or GLP-1 RAs.
- •[26] Have had an MI, percutaneous coronary revascularization
- •procedure, ischemic stroke, carotid stenting or surgical
- •revascularization, nontraumatic amputation or peripheral vascular
- •procedure (eg, stenting or surgical revascularization) less than 60 days
- •prior to screening.
- •[27] Have had coronary artery bypass graft surgery less than 5 years prior to Screening.
- •[28] Treatment with GLP-1 RA, or pramlintide in a period of 3 months
- •prior to Visit 1.
- •[29] Discontinuation of GLP-1 RA, or pramlintide due to intolerability any
- •time prior to Visit 1.
- •[30] Exclusion Criterion [30] has been deleted.
- •[31] Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •[32] Have participated within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-lif
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